MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-08-18 for AMS INFLATABLE PENILE PROSTHESIS manufactured by American Medical Systems Inc.
[23228837]
The following elements have blank data
Patient Sequence No: 1, Text Type: N, H10
[23228838]
Patient was admitted for replacement/revision of inflatable penile prosthesis that was implanted approximately five years ago. Last year, surgeon reports the device was not working well and approximately four months ago this year, the device was not functioning at all. Patient was able to achieve erection, but immediately subsides after pumping the inflatable penile prosthesis. Surgeon noted appearance of fluid on exam and this is consistent with a nonfunctioning lockout valve. Device was removed and replaced with ams implanted device. Patient had no post-op complications and was discharged home the day after surgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5009792 |
| MDR Report Key | 5009792 |
| Date Received | 2015-08-18 |
| Date of Report | 2015-08-11 |
| Date of Event | 2015-06-01 |
| Report Date | 2015-08-11 |
| Date Reported to FDA | 2015-08-11 |
| Date Reported to Mfgr | 2015-08-11 |
| Date Added to Maude | 2015-08-18 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AMS INFLATABLE PENILE PROSTHESIS |
| Generic Name | PENILE PROSTHESIS |
| Product Code | JCW |
| Date Received | 2015-08-18 |
| Device Availability | Y |
| Device Age | 5 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AMERICAN MEDICAL SYSTEMS INC |
| Manufacturer Address | 10700 BREN ROAD WEST MINNETONKA MN 55343 US 55343 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-08-18 |